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Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

Primary Purpose

HIV Infection

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Integrated care centers
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infection focused on measuring HIV, injection drug use, men who have sex with men, voluntary counselling and testing, risk reduction, sexually transmitted infections, community viral load, antiretroviral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Key Informant Interviews:

Persons may be included in the key informant interviews if they meet all of the following criteria:

  1. 18 years of age or older
  2. Knowledge of the local HIV risk group of interest (IDU or MSM)
  3. Psychologically fit to participate in the study and to understand the consent
  4. Ability to comprehend one of the consent translation languages
  5. Provide informed consent

Focus groups:

Persons may be included in the focus groups if they meet all of the following criteria:

  1. 18 years of age or older

  2. Member of a target HIV risk group, meeting criterion 2a or 2b

    1. IDU: self-reported injection drug use in prior 12 months
    2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
  3. Psychologically fit to participate in the study and to understand the consent
  4. Ability to comprehend one of the consent translation languages
  5. Provide informed consent

Baseline or evaluation respondent-driven sampling (RDS) survey

Persons may be included in the baseline or evaluation RDS survey if they meet all of the following criteria:

  1. 18 years of age or older

  2. Member of a target HIV risk group, meeting criterion 2a or 2b

    1. IDU: self-reported injection drug use in prior 24 months
    2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
  3. Psychologically fit to participate in the study and to understand the consent
  4. Ability to comprehend one of the consent translation languages
  5. Present a valid RDS referral coupon (unless a seed)
  6. Provide informed consent

Exclusion Criteria:

Key Informant Interviews:

Persons will be excluded from the key informant interviews if they meet any of the following criteria:

  1. Younger than 18 years
  2. Do not have knowledge of the local HIV risk group of interest (IDU or MSM)
  3. Are not psychologically fit to participate in the study or to understand the consent
  4. Do not have ability to comprehend one of the consent translation languages
  5. Do not provide informed consent

Focus groups:

Persons will be excluded from the focus groups if they meet any of the following criteria:

  1. Younger than 18 years

  2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b

    1. IDU: self-reported injection drug use in prior 12 months
    2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
  3. Are not psychologically fit to participate in the study or to understand the consent
  4. Do not have ability to comprehend one of the consent translation languages
  5. Do not provide informed consent

Baseline or evaluation RDS survey

Persons will be excluded in the baseline or evaluation RDS survey if they meet any of the following criteria:

  1. Younger than 18 years

  2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b

    1. IDU: self-reported injection drug use in prior 24 months
    2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
  3. Are not psychologically fit to participate in the study or to understand the consent
  4. Do not have ability to comprehend one of the consent translation languages
  5. Do not present a valid RDS referral coupon and are not a seed
  6. Do not provide informed consent

Sites / Locations

  • YR Gaitonde Center for AIDS Research and Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrated care centers

Standard services

Arm Description

Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. HIV voluntary counseling and testing & staging Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy Substance abuse counseling Sexually transmitted infection screening and treatment Access to free antiretroviral therapy and adherence support Peer community outreach

In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.

Outcomes

Primary Outcome Measures

Proportion Reporting HIV Testing in the Prior 12 Months
Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.

Secondary Outcome Measures

Proportion of HIV-infected Participants Aware of Status
Proportion of HIV-positive participants that were aware of their status at the time of the visit
Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months
Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy
Community Viral Load
Average log(10) HIV RNA concentration among HIV-infected participants
Proportion of HIV-infected Participants With Suppressed HIV RNA
Proportion of HIV-positive participants meeting criteria for antiretroviral therapy [cluster of differentiation 4 (CD4) count <350 cells/mm3 or current or past use of antiretroviral therapy)] who have a suppressed viral load (HIV RNA <150 copies/mL)
Prevalence of Recent HIV Infection
Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months
Proportion of IDU Reporting Drug Abstinence in Prior 6 Months
Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months
Number of Non-main Male Partners in Prior 6 Months in MSM
Proportion Reporting Substance Abuse Among MSM
Proportion With Depressive Symptoms
Participants with Score >=10 on Patient Health Questionnaire-9
Number of Unprotected Sexual Acts Reported by MSM
Vicarious Stigma as Assessed by 6-item Stigma Scale
Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma
Proportion Reporting Spouse Ever Tested for HIV

Full Information

First Posted
September 13, 2012
Last Updated
June 26, 2019
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), YR Gaitonde Centre for AIDS Research and Education, Elton John AIDS Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01686750
Brief Title
Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations
Official Title
A Cluster Randomized Trial of Integrated Care Centers to Improve Access to HIV Prevention, Testing, and Treatment Services Among High-Risk Vulnerable Populations in India
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), YR Gaitonde Centre for AIDS Research and Education, Elton John AIDS Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a cluster randomized trial to evaluate the effectiveness of integrated care centers (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to stratify sites according to key baseline characteristics. We will perform stratified randomization to assign sites to either the ICC intervention or to standard services. ICCs, which will be either IDU or MSM-focused, will provide an accepting atmosphere in which members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be scaled-up from existing governmental or non-governmental organizations and services provided at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After providing services in communities for two years, we will conduct an evaluation survey (with biological and behavioral measures) of approximately 1000 subjects in the target populations in each of the 22 study sites. Integrated care centers have the potential to improve access to HIV prevention and treatment services among vulnerable, high-risk populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, injection drug use, men who have sex with men, voluntary counselling and testing, risk reduction, sexually transmitted infections, community viral load, antiretroviral therapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21726 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated care centers
Arm Type
Experimental
Arm Description
Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. HIV voluntary counseling and testing & staging Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy Substance abuse counseling Sexually transmitted infection screening and treatment Access to free antiretroviral therapy and adherence support Peer community outreach
Arm Title
Standard services
Arm Type
No Intervention
Arm Description
In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Intervention Type
Behavioral
Intervention Name(s)
Integrated care centers
Primary Outcome Measure Information:
Title
Proportion Reporting HIV Testing in the Prior 12 Months
Description
Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Proportion of HIV-infected Participants Aware of Status
Description
Proportion of HIV-positive participants that were aware of their status at the time of the visit
Time Frame
2 years
Title
Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months
Time Frame
2 years
Title
Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy
Time Frame
2 years
Title
Community Viral Load
Description
Average log(10) HIV RNA concentration among HIV-infected participants
Time Frame
2 years
Title
Proportion of HIV-infected Participants With Suppressed HIV RNA
Description
Proportion of HIV-positive participants meeting criteria for antiretroviral therapy [cluster of differentiation 4 (CD4) count <350 cells/mm3 or current or past use of antiretroviral therapy)] who have a suppressed viral load (HIV RNA <150 copies/mL)
Time Frame
2 years
Title
Prevalence of Recent HIV Infection
Time Frame
2 years
Title
Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months
Time Frame
2 years
Title
Proportion of IDU Reporting Drug Abstinence in Prior 6 Months
Time Frame
2 years
Title
Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months
Time Frame
2 years
Title
Number of Non-main Male Partners in Prior 6 Months in MSM
Time Frame
2 years
Title
Proportion Reporting Substance Abuse Among MSM
Time Frame
2 years
Title
Proportion With Depressive Symptoms
Description
Participants with Score >=10 on Patient Health Questionnaire-9
Time Frame
2 years
Title
Number of Unprotected Sexual Acts Reported by MSM
Time Frame
2 years
Title
Vicarious Stigma as Assessed by 6-item Stigma Scale
Description
Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma
Time Frame
2 years
Title
Proportion Reporting Spouse Ever Tested for HIV
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Key Informant Interviews: Persons may be included in the key informant interviews if they meet all of the following criteria: 18 years of age or older Knowledge of the local HIV risk group of interest (IDU or MSM) Psychologically fit to participate in the study and to understand the consent Ability to comprehend one of the consent translation languages Provide informed consent Focus groups: Persons may be included in the focus groups if they meet all of the following criteria: 18 years of age or older Member of a target HIV risk group, meeting criterion 2a or 2b IDU: self-reported injection drug use in prior 12 months MSM: self-identify as male and report oral/anal sex with another male in prior 12 months Psychologically fit to participate in the study and to understand the consent Ability to comprehend one of the consent translation languages Provide informed consent Baseline or evaluation respondent-driven sampling (RDS) survey Persons may be included in the baseline or evaluation RDS survey if they meet all of the following criteria: 18 years of age or older Member of a target HIV risk group, meeting criterion 2a or 2b IDU: self-reported injection drug use in prior 24 months MSM: self-identify as male and report oral/anal sex with another male in prior 12 months Psychologically fit to participate in the study and to understand the consent Ability to comprehend one of the consent translation languages Present a valid RDS referral coupon (unless a seed) Provide informed consent Exclusion Criteria: Key Informant Interviews: Persons will be excluded from the key informant interviews if they meet any of the following criteria: Younger than 18 years Do not have knowledge of the local HIV risk group of interest (IDU or MSM) Are not psychologically fit to participate in the study or to understand the consent Do not have ability to comprehend one of the consent translation languages Do not provide informed consent Focus groups: Persons will be excluded from the focus groups if they meet any of the following criteria: Younger than 18 years Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b IDU: self-reported injection drug use in prior 12 months MSM: self-identify as male and report oral/anal sex with another male in prior 12 months Are not psychologically fit to participate in the study or to understand the consent Do not have ability to comprehend one of the consent translation languages Do not provide informed consent Baseline or evaluation RDS survey Persons will be excluded in the baseline or evaluation RDS survey if they meet any of the following criteria: Younger than 18 years Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b IDU: self-reported injection drug use in prior 24 months MSM: self-identify as male and report oral/anal sex with another male in prior 12 months Are not psychologically fit to participate in the study or to understand the consent Do not have ability to comprehend one of the consent translation languages Do not present a valid RDS referral coupon and are not a seed Do not provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory M Lucas, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shruti Mehta, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David D Celentano, ScD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suniti Solomon, MD
Organizational Affiliation
YR Gaitonde Centre for AIDS Research and Education
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aylur Srikrishnan, BA
Organizational Affiliation
YR Gaitonde Centre for AIDS Research and Education
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suresh Kumar, MPH
Organizational Affiliation
YR Gaitonde Centre for AIDS Research and Education
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sunil S Solomon, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
YR Gaitonde Center for AIDS Research and Education
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600113
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
25849835
Citation
Solomon SS, Mehta SH, Srikrishnan AK, Vasudevan CK, Mcfall AM, Balakrishnan P, Anand S, Nandagopal P, Ogburn EL, Laeyendecker O, Lucas GM, Solomon S, Celentano DD. High HIV prevalence and incidence among MSM across 12 cities in India. AIDS. 2015 Mar 27;29(6):723-31. doi: 10.1097/QAD.0000000000000602.
Results Reference
background
PubMed Identifier
25715105
Citation
Lucas GM, Solomon SS, Srikrishnan AK, Agrawal A, Iqbal S, Laeyendecker O, McFall AM, Kumar MS, Ogburn EL, Celentano DD, Solomon S, Mehta SH. High HIV burden among people who inject drugs in 15 Indian cities. AIDS. 2015 Mar 13;29(5):619-28. doi: 10.1097/QAD.0000000000000592.
Results Reference
background
PubMed Identifier
25486851
Citation
Solomon SS, Mehta SH, Srikrishnan AK, Solomon S, McFall AM, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Lucas GM, Kumar MS, Sulkowski MS, Quinn TC. Burden of hepatitis C virus disease and access to hepatitis C virus services in people who inject drugs in India: a cross-sectional study. Lancet Infect Dis. 2015 Jan;15(1):36-45. doi: 10.1016/S1473-3099(14)71045-X. Epub 2014 Dec 3.
Results Reference
background
PubMed Identifier
23801014
Citation
Solomon SS, Lucas GM, Celentano DD, Sifakis F, Mehta SH. Beyond surveillance: a role for respondent-driven sampling in implementation science. Am J Epidemiol. 2013 Jul 15;178(2):260-7. doi: 10.1093/aje/kws432. Epub 2013 Jun 25.
Results Reference
background
PubMed Identifier
27842543
Citation
Solomon SS, Lucas GM, Celentano DD, McFall AM, Ogburn E, Moulton LH, Srikrishnan AK, Kumar MS, Anand S, Solomon S, Mehta SH. Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India. BMC Health Serv Res. 2016 Nov 14;16(1):652. doi: 10.1186/s12913-016-1905-5.
Results Reference
background
PubMed Identifier
26251048
Citation
Mehta SH, Lucas GM, Solomon S, Srikrishnan AK, McFall AM, Dhingra N, Nandagopal P, Kumar MS, Celentano DD, Solomon SS. HIV care continuum among men who have sex with men and persons who inject drugs in India: barriers to successful engagement. Clin Infect Dis. 2015 Dec 1;61(11):1732-41. doi: 10.1093/cid/civ669. Epub 2015 Aug 6.
Results Reference
background
PubMed Identifier
30952565
Citation
Solomon SS, Solomon S, McFall AM, Srikrishnan AK, Anand S, Verma V, Vasudevan CK, Balakrishnan P, Ogburn EL, Moulton LH, Kumar MS, Sachdeva KS, Laeyendecker O, Celentano DD, Lucas GM, Mehta SH; Indian National Collaboration on AIDS Study. Integrated HIV testing, prevention, and treatment intervention for key populations in India: a cluster-randomised trial. Lancet HIV. 2019 May;6(5):e283-e296. doi: 10.1016/S2352-3018(19)30034-7. Epub 2019 Apr 2.
Results Reference
result
PubMed Identifier
35410326
Citation
Prabhu S, Mehta SH, McFall AM, Srikrishnan AK, Vasudevan CK, Lucas GM, Celentano DD, Solomon SS. Substance use is associated with condomless anal intercourse among men who have sex with men in India: a partner-level analysis. BMC Public Health. 2022 Apr 11;22(1):722. doi: 10.1186/s12889-022-13192-y.
Results Reference
derived
PubMed Identifier
31604081
Citation
Solomon SS, Quinn TC, Solomon S, McFall AM, Srikrishnan AK, Verma V, Kumar MS, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Thomas DL, Sachdeva KS, Lucas GM, Mehta SH. Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial. J Hepatol. 2020 Jan;72(1):67-74. doi: 10.1016/j.jhep.2019.09.022. Epub 2019 Oct 8.
Results Reference
derived
PubMed Identifier
27036994
Citation
Solomon SS, Mehta SH, McFall AM, Srikrishnan AK, Saravanan S, Laeyendecker O, Balakrishnan P, Celentano DD, Solomon S, Lucas GM. Community viral load, antiretroviral therapy coverage, and HIV incidence in India: a cross-sectional, comparative study. Lancet HIV. 2016 Apr;3(4):e183-90. doi: 10.1016/S2352-3018(16)00019-9. Epub 2016 Mar 11.
Results Reference
derived

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Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

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